Pristiq (Desvenlafaxine Succinate) - Summary

PRISTIQ SUMMARY

MEDICATION GUIDE

Pristiq is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O‑desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive, generalized anxiety, social anxiety and panic disorders.

Pristiq, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [ see Clinical Studies (14) and Dosage and Administration (2.1) ]. The efficacy of Pristiq has been established in four 8-week, placebo-controlled studies of outpatients who met DSM-IV criteria for major depressive disorder.

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.

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NEWS HIGHLIGHTS

Media Articles Related to Pristiq (Desvenlafaxine)

Women At Risk Of Post Natal Depression May Be Identified By Blood Test
Source: Health News from Medical News Today [2012.05.18]
Researchers at Warwick Medical School have discovered a way of identifying which women are most at risk of postnatal depression (PND) by checking for specific genetic variants. The findings could lead to the development of a simple, accurate blood test which checks for the likelihood of developing the condition...

Study Suggests Nature Walks Improve Cognitive Abilities For People With Clinical Depression
Source: Depression News From Medical News Today [2012.05.15]
A walk in the park may have psychological benefits for people suffering from depression. In one of the first studies to examine the effect of nature walks on cognition and mood in people with major depression, researchers in Canada and the U.S. have found promising evidence that a walk in the park may provide some cognitive benefits...

10-Year Roadmap To Prevent, Fight Depression
Source: Depression News From Medical News Today [2012.05.15]
Major depressive episodes can be prevented, and to help ensure that they are, the health care system should provide routine access to depression-prevention interventions, just as patients receive standard vaccines, according to a new article co-authored by UCSF researcher Ricardo F. Munoz, PhD...

Depression
Source: MedicineNet Alcohol Abuse and Alcoholism Specialty [2012.05.15]
Title: Depression
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 5/15/2012 12:00:00 AM

Quality Of Life And Symptoms Rapidly And Significantly Improved By Non-Drug Depression Treatment
Source: Anxiety / Stress News From Medical News Today [2012.05.10]
New data released at the annual meeting of the American Psychiatric Association show that patients with unipolar, non-psychotic Major Depressive Disorder (MDD) receiving transcranial magnetic stimulation (TMS) with NeuroStar TMS Therapy® achieved significant improvements in both depression symptoms and in quality of life measurements...

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Published Studies Related to Pristiq (Desvenlafaxine)

Randomized placebo- and active-controlled study of desvenlafaxine for menopausal vasomotor symptoms. [2011.11.08]
ABSTRACT Objective To evaluate the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) vs... Adverse drug reactions were consistent with the known safety profile of desvenlafaxine, and significantly more women who received tibolone experienced episodes of bleeding compared with women who received desvenlafaxine or placebo.

Open-label treatment with desvenlafaxine in postmenopausal women with major depressive disorder not responding to acute treatment with desvenlafaxine or escitalopram. [2011.03.01]
BACKGROUND: Preliminary clinical evidence indicates that menopausal status might impact on the efficacy of certain classes of antidepressants. OBJECTIVE: The aim of this study was to evaluate open-label desvenlafaxine treatment (administered as desvenlafaxine succinate) in postmenopausal women who did not achieve clinical response to acute, double-blind treatment with desvenlafaxine or escitalopram... CONCLUSIONS: Postmenopausal women with major depressive disorder who did not respond to acute, double-blind treatment with escitalopram or desvenlafaxine achieved modest, continued improvement with long-term, open-label desvenlafaxine therapy. Further interpretation of these findings is limited by aspects of the study design (i.e. open-label, non-placebo-controlled) and the lack of randomized comparison groups in the extension phase, which prevents statistical assessment of the efficacy of longer term treatment with desvenlafaxine. Clinicaltrials.gov identifier: NCT00406640.

Pharmacokinetics of venlafaxine extended release 75 mg and desvenlafaxine 50 mg in healthy CYP2D6 extensive and poor metabolizers: a randomized, open-label, two-period, parallel-group, crossover study. [2011]
BACKGROUND: Genetically driven variations in the level of cytochrome P450 (CYP) 2D6 metabolic activity have been shown to significantly affect the pharmacokinetic behaviour of medications that are substrates of this enzyme. OBJECTIVE: To evaluate the impact of CYP2D6 extensive metabolizer (EM) and poor metabolizer (PM) phenotypes on the pharmacokinetics of single doses of venlafaxine extended release (ER) and desvenlafaxine (administered as desvenlafaxine succinate)... CONCLUSION: In contrast to venlafaxine ER 75 mg, the pharmacokinetics of desvenlafaxine 50 mg is not significantly impacted by CYP2D6 genetic polymorphisms. PMs receiving venlafaxine ER 75 mg had significantly lower O-desmethylvenlafaxine and higher venlafaxine plasma concentrations.

Short-term efficacy and safety of desvenlafaxine in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder. [2010.08]
CONCLUSIONS: Short-term treatment with desvenlafaxine was effective and generally well tolerated in perimenopausal and postmenopausal women with MDD. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00369343. Copyright 2010 Physicians Postgraduate Press, Inc.

Desvenlafaxine and escitalopram for the treatment of postmenopausal women with major depressive disorder. [2010.07]
OBJECTIVE: This study assessed the efficacy, safety, and tolerability of the serotonin-norepinephrine reuptake inhibitor desvenlafaxine and the selective serotonin reuptake inhibitor escitalopram for major depressive disorder (MDD) in postmenopausal women... CONCLUSIONS: Among postmenopausal outpatients with MDD, there were no significant differences in the efficacy of desvenlafaxine and escitalopram based on primary efficacy analyses. The results do not support the overall hypothesis that the serotonin-norepinephrine reuptake inhibitor desvenlafaxine has an efficacy advantage for the treatment of MDD in postmenopausal women because, in this particular subgroup, desvenlafaxine failed to prove superiority over escitalopram. Safety and tolerability were comparable.

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Clinical Trials Related to Pristiq (Desvenlafaxine)

12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder [Recruiting]

Desvenlafaxine Succinate (Pristiq) Postmarketing Surveillance Among Filipinos [Not yet recruiting]
This is a non-interventional study to review safety data on administration of desvenlafaxine succinate among Filipinos per usual clinical practice within the first three years post commercial distribution.

Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet [Recruiting]
To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.

Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR) [Recruiting]

Desvenlafaxine Succinate (DVS) for Major Depressive Disorder (MDD) in Midlife Men and Women [Recruiting]
The main objective of this study is to characterize a range of brain activation symptoms associated with depression and response to treatment in midlife men and women with MDD, using MRI and functional MRI. Moreover, in the female sub-group, the investigators will examine whether these brain activation symptoms are related to menopausal symptoms (i. e., hot flashes and night sweats). Also, assessing brain activation before and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.

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PATIENT REVIEWS / RATINGS / COMMENTS

Pristiq review by 52 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Depression
Dosage & duration:		50mg taken once daily for the period of I have been taking this drug for 6 month
Other conditions:		anxiety
Other drugs taken:		xanax
		Reported Results
Benefits:		This is an NSRI, different from an SSRI because it works on more than one brain chemical. When an SSRI is ineffective or a patient finds that after a period of time a working drug stops working and symptoms of depression return they may be advised to try an NSRI. This was the case with me. I have been treated for my depression for years and had done extremely well for periods of time on several different drugs at different times. Moving from one to the next as I bottomed out on each. Celexa and Lexapro being the most recent. When Lexapro let me down after a couple of years I was advised to try Pristiq which was just released only a few months before my doctor suggested it. I was extremely hesitant as I did not want to go through another adjustment period of sleeplessness, headaches, possible weight gain, sexual issues, etc. You know the drill if you have taken drugs for deperession. So I chose to stay on my Lexapro and be depressed, hoping that it would start working again at a higher dose. Wrong. Getting to the end of my rope with my depression I finally decided to bite the bullet and try the Prestiq. My depression disappeared within 3 weeks leaving me feeling better than I had in months. I began smiling again and fully functioning doing the things I enjoy and had let slide. My sense of well being and hopefulness for the future returned.
Side effects:		Honestly, none for me. I sleep, did not gain an ounce, in fact I lost a small amount of weight even though I did not need to, no sexual side effect at all! Only thing that was tough was waiting for the dosage level to become theraputic in my system, which as I mentioned took about 3 weeks.
Comments:		I was instructed to continue on the Lexapro at a lower dose for one week. At the 2nd week add my dose of Pristiq to the lower dose of Lexapro, at the 3rd week drop the Lexapro completely and continue on my dose of Pristiq. This was done while staying in contact with my prescribing doctor. Now I take 1 50mg tablet everyday of Pristiq, and am doing very well.

Pristiq review by 47 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		depression
Dosage & duration:		40 mg taken once daily for the period of two years
Other conditions:		ADHD
Other drugs taken:		Vyvanse
		Reported Results
Benefits:		Pristiq elevated mood and energy levels.
Side effects:		Increased anxiety
Comments:		Pristiq was prescribed at a 20 mg dose and then increased to 40 mg dose. I continue to take it as it has been the most effective medication for alleviating symptoms of depression that I have tried, including Prozac, Effexor, Wellbutrin and Lexapro.

Pristiq review by 53 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		severe depression
Dosage & duration:		50mg taken 50 mg once daily for the period of little more than 2 weeks
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I had no benefits
Side effects:		Nausea, dizziness, increased anxiety, and extreme irritibility.
Comments:		I could not control my irritability. It was out of control. I felt like I was not myself. When starting my third week on this med, I stopped. By day two I felt much better. Would not try this drug again. Had only slight nausea after stopping this medications that quickly went away. My depression worsened on this med. Would not recommend.